A Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 Subcutaneously (SC) Compared to Actemra® in Healthy Male Participants

NCT06262477 | Completed Phase 1 Results FDA Drug

• 1 other identifier: NL-TCZ-12280
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 4

Brief Summary

The primary objective of the study is to show equivalence in pharmacokinetics (PK) of BIIB800 and Actemra following SC administration of a single dose to healthy male participants. The secondary objective of the study is to evaluate PK over time, clinical safety, pharmacodynamic (PD) profiles and immunogenicity of BIIB800 and Actemra.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Serum Concentration (Cmax) of Tocilizumab

  Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)

• Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Tocilizumab

  Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)

• Area Under the Concentration-Time Curve up to the Last Measurable Concentration (AUC0-t) of Tocilizumab

  Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)

Secondary Outcomes (12)

• Time to Reach Cmax (Tmax) of BIIB800 and Tocilizumab

  Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)

• Apparent Total Body Clearance (CL/F) of BIIB800 and Actemra

  Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)

• Apparent Terminal Half-Life (t1/2) of BIIB800 and Actemra

  Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious AEs (TESAEs)

  From the first dose of study drug up to the end of the study (up to Day 57)

• Area Under the Effect-Time Curve (AUE) of Soluble Interleukin-6-Receptor (sIL-6R)

  Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)

Study Arms (2)

BIIB800

EXPERIMENTAL

Participants will receive a single dose of BIIB800 via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.

Drug: BIIB800

Actemra

EXPERIMENTAL

Participants will receive a single dose of Actemra via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.

Drug: Actemra

Interventions

BIIB800 DRUG

Administered as specified in the treatment arm.

Also known as: BAT1806

BIIB800

Actemra DRUG

Administered as specified in the treatment arm.

Also known as: Tocilizumab, RoActemra

Actemra

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Have a body mass index between 18.5 and 29.9 kilograms per meter square (kg/m\^2), inclusive.
• Total body weight between 60.0 and 90.0 kg, inclusive.
• Systolic blood pressure \<135 millimeters of mercury (mmHg) or \>85 mmHg at Screening, after being supine for at least 5 minutes.
• No clinically significant (as determined by the Investigator) 12-lead electrocardiogram (ECG) abnormalities, no cardiac pacemaker.

You may not qualify if:

• History or positive test result at Screening for human immunodeficiency virus (HIV).
• History of hepatitis C infection or positive test result at Screening for hepatitis C virus antibody.
• Current hepatitis B infection (defined as positive for hepatitis B surface antigen \[HBsAg\] and total hepatitis B core antibody \[anti-HBc\]).
• Serious infection (as determined by the Investigator) within the 6 months prior to Screening.
• History of systemic hypersensitivity reaction to the active drug substance, the excipients contained in the formulation, and if appropriate, any diagnostic agents to be administered during the study.
• History of immunodeficiency or other clinically significant immunological disorders, or autoimmune disorders.
• History of clinically significant (in the opinion of the Investigator) atopic allergy (e.g., asthma, urticaria, eczematous dermatitis, allergic rhinitis), hypersensitivity, or allergic reactions.
• History of angioedema.
• A positive diagnostic tuberculosis test result within 35 days prior to Day -1, defined as a positive QuantiFERON® test result or 2 successive indeterminate QuantiFERON test results.
• Any prior exposure to tocilizumab or to any other agent directly acting on IL-6 or on its receptors including investigational products (e.g., siltuximab, sarilumab etc.).
• Administration of immunoglobulins for anti-tetanus and anti-rabies post-exposure prophylaxis within 3 weeks prior to administration of study drug.
• Any live or attenuated immunization or vaccination given within 30 days prior to Day -1 or planned to be given during the study period.

Sponsors & Collaborators

• Biogen: lead

Study Sites (4)

Fortrea Clinical Research Unit Inc.

Daytona Beach, Florida, 32117, United States

Location

Fortrea Clinical Research Unit Inc.

Dallas, Texas, 75247, United States

Location

Fortrea Clinical Research Unit Inc.

Madison, Wisconsin, 53704, United States

Location

Fortrea Clinical Research Unit Inc.

Leeds, West Yorkshire, LS2 9LH, United Kingdom

Location

MeSH Terms

Interventions

tocilizumab

Results Point of Contact

• Title: US Biogen Clinical Trial Center
• Organization: Biogen

clinicaltrials@biogen.com

866-633-4636

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 16, 2024
• Study Start: January 2, 2024
• Primary Completion: September 25, 2024
• Study Completion: October 4, 2024
• Last Updated: October 6, 2025
• Results First Posted: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (3); GB (1)